Atracurium Besylate Injection

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Prescribing Information

Atracurium Besylate Injection is a skeletal muscle relaxant used in addition to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. This medication is available in generic form. Common side effects include skin flushing or redness, hives, itching, or wheezing.

An atracurium besylate dose of 0.4 to 0.5 mg/kg (1.7 to 2.2 times the ED95), given as an intravenous bolus injection, is the recommended initial dose for most patients. Atracurium besylate injection may interact with enflurane, isoflurane, halothane, antibiotics, lithium, magnesium salts, procainamide, quinidine, other muscle relaxants, and succinylcholine. Tell your doctor all medications and supplements you use. During pregnancy, atracurium besylate should be used only if prescribed It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Atracurium Besylate Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

SIDE EFFECTS

Observed in Controlled Clinical Studies: Atracurium was well tolerated
and produced few adverse reactions during extensive clinical trials. Most adverse
reactions were suggestive of histamine release. In studies including 875 patients,
atracurium was discontinued in only one patient (who required treatment for
bronchial secretions) and six other patients required treatment for adverse
reactions attributable to atracurium (wheezing in one, hypotension in five).
Of the five patients who required treatment for hypotension, three had a history
of significant cardiovascular disease. The overall incidence rate for clinically
important adverse reactions, therefore, was 7/875 or 0.8%.

Table 1 includes all adverse reactions reported attributable to atracurium
during clinical trials with 875 patients.

Most adverse reactions were of little clinical significance unless they were
associated with significant hemodynamic changes. Table 2 summarizes the incidences
of substantial vital sign changes noted during atracurium clinical trials with
530 patients, without cardiovascular disease, in whom these parameters were
assessed.

Observed in Clinical Practice: Based on initial clinical practice experience
in approximately 3 million patients who received atracurium in the U.S. and
in the United Kingdom, spontaneously reported adverse reactions were uncommon
(approximately 0.01% to 0.02%). The following adverse reactions are among the
most frequently reported, but there are insufficient data to support an estimate
of their incidence:

There have been rare spontaneous reports of seizures in ICU patients following
long-term infusion of atracurium to support mechanical ventilation. There are
insufficient data to define the contribution, if any, of atracurium and/or its
metabolite laudanosine. (See PRECAUTIONS: Long-Term
Use in Intensive Care Unit [lCU]).